Quality , Science, Pharmaceutical & Food

Quality & Regulatory Specialist

  • Full Time
  • Remote
  • Munster
  • 41969142

PE Global is currently recruiting for a Quality & Regulatory Specialist for a leading mu client based in Little Island Cork.

This is a permanent position.


  • Ensures compliance with cGMP’s & Environmental, Health & Safety regulations.
  • Ensure compliance & execute all activities to the BluePoint Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
  • Executes the finished product non-conformance process.
  • Supports document reviews to ensure timely release of finished product.
  • Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
  • Manages & executes all routine regulatory updates & submissions of finished product labelling.
  • Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
  • Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
  • Ensures the company and product is registered in the appropriate markets & with agencies as required.
  • Reviews and approves product labeling, patient package inserts and other product labeling.
  • Executes the document control system & record retention.
  • Develops, implements and maintains Standard Operating Procedures.
  • Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
  • Maintain familiarity with current regulatory trends.
  • Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
  • Performs related duties as assigned.


  • Minimum requirement of a BSc in a scientific discipline; minimum of five (5) years in a cGMP facility in a Quality Assurance role.
  • Essential to have good communication and attention to detail.
  • Experience in the Pharmaceutical industry is essential.
  • Experience in Medical Device regulations is desirable but not essential.
  • Excellent oral and written communication skills
  • Ability to effectively manage and participate in cross-functional problem-solving teams
  • Ability to read and understand the English language for the purpose of following instructions
  • Ability to develop and maintain cooperative working relationships with others.
  • Ability to use good judgment in order to carry out detailed instructions
  • Ability to work independently
  • Excellent teamwork and interpersonal skills
  • Ability to handle a variety of tasks simultaneously
  • Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
  • Ability to apply critical thinking on review of all quality related procedures and documents
  • Excellent attention to detail
  • Artwork review/Regulatory experience desirable
  • Supplier Quality
  • Quality Systems
  • Computer literate; Excel, Word, Document Management System, etc..
  • Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up-to-date CV to Niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***


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